Kornimate/medical-research-clean huggingface dataset:
bilicurves: using information technology to improve the management of neonatal hyperbilirubinemia

Conditions: Neonatal Hyperbilirubinemia

Summary: we will use information technology to integrate the 2004 american academy of pediatrics guidelines for management of neonatal hyperbilirubinemia with laboratory reporting of newborn bilirubin test results to improve physician adherence to the guidelines and quality of care.

in 2004, the american academy of pediatrics disseminated clinical practice guidelines for the management of neonatal hyperbilirubinemia. using the infant's age in hours, serum bilirubin levels are applied to hour-specific nomograms to assess risk of developing significant hyperbilirubinemia as well as the necessity for treatment. prior guidelines did not include nomograms for either. a systems approach to managing neonatal hyperbilirubinemia, including use of the nomograms, has been shown to improve outcomes and patient safety. despite the existence of these guidelines, decision support does not exist within mgh clinical information systems for managing neonatal hyperbilirubinemia. we propose to create bilicurves, an application that integrates perinatal information from the obstetrical health record with that of the newborn's, providing seamless reporting of neonatal bilirubin results in the context of the practice guidelines and relevant obstetrical data. bilicurves will graphically superimpose bilirubin results onto hour-specific guideline nomograms that providers can view when viewing bilirubin results. we propose to randomize bilicurves access to pediatric providers, and study its effects on management of hyperbilirubinemia both during birth hospitalization as well as in the outpatient setting after discharge. we hypothesize infants treated by physicians with bilicurves access will receive birth hospitalization phototherapy at a higher rate and readmission for hyperbilirubinemia at a lower rate than that of the control group. we also hypothesize that physicians with bilicurves access will report greater ease and confidence in nomogram use and providing evidence-based care as bilicurves obviates the provider having to have access to paper based versions of the nomogram (usual care) as well decreases potential errors in plotting test results on the nomograms.

Eligibility criteria:
inclusion criteria: * providers who care for infants in the newborn nursery. * all newborns in the newborn nursery that are 35 weeks or more weeks of gestation will be study eligible. exclusion criteria: * infants less than 35 weeks gestation.
quantification of breast sensation following postmastectomy breast reconstruction

Conditions: Breast Cancer; Cancer

Summary: the purpose of this study is to evaluate the return of sensation in the breast(s) following breast mastectomy with and without reconstruction. four different sensations: touch, vibration, superficial pain, and temperature will be evaluated. in addition, we will look at factors that may contribute to the return of breast sensations.

this study entitled "the quantification of breast sensations following postmastectomy breast reconstruction" will evaluate the recovery of sensation in the reconstructed as well as in the nonreconstructed breast. touch, vibration, pain and temperature sensation will be objectively evaluated greater than 1 year following completion of reconstruction. breast sensation following immediate, tissue expander/implant breast reconstruction will be compared with that following immediate, autogenous tissue reconstruction. a formal sensory examination will be performed. semmesweinstein monofilaments will evaluate touchpressure sensation in the breast. a bioesthesiometer will determine the recovery of vibratory sensation. temperature sensation will be evaluated by application of warm and cool stimuli. superficial pain sensation will be evaluated by application of sharp and dull stimuli. a patient reported assessment of sensory changes in the breast will be administered to patients. the breast sensation assessment scale © is designed to measure the prevalence, severity, and distress of 18 different sensory symptoms following breast surgery. a "patient demographic and treatment information form" and patients' medical records will be used to obtain demographic and treatment data. the role of confounding variables (including: patient age, breast volume, axillary procedures performed and adjuvant therapies received) on the recovery of sensation will be evaluated. the estimated accrual time for this study is 12 months.

Eligibility criteria:
inclusion criteria: * patients who have undergone mastectomy * patients who have undergone immediate, twostage expander/implant breast reconstruction * patients who have undergone immediate, autogenous tissue flap reconstruction including: pedicled and/or free tram flap or diep flap reconstruction * patients at least 21 years of age * patients at least 1 year from the time of mastectomy or completion of immediate, postmastectomy reconstruction exclusion criteria: patients who have had any of the following: * delayed reconstruction (no reconstruction immediately after mastectomy) * combined autogenous tissue/implant breast reconstruction * tissue expander * patients who have a history of complex regional pain syndrome * implant explantation (device is removed prematurely due to complications)

Keywords: breast cancer cancer breast sensation postmastectomy breast reconstruction
pregnancy registry in mali

Conditions: Malaria; Pregnancy Related

Summary: this registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in kalifabougou, mali.

this pregnancy registry will gather background data on pregnancy rates and outcomes as well as infant health data to inform future implementation of clinical trials testing monoclonal antibodies (mabs) to prevent malaria in pregnancy. in the first part of the study (community census cohort), women of child-bearing age (wocba) in the community will be identified and followed for up to 3 years to detect pregnancy at all stages. upon detection of pregnancy, these women may then transition to participation in the health facility cohort. in the second part of the study (health facility cohort), data will be prospectively collected from pregnant women presenting at the health facility for antenatal care (anc) visits or referred in from the community census cohort. the pregnant women will be followed through pregnancy outcome and until 12 months postpartum, and their infant(s) will be followed until 12 months of age. the study team will collect baseline information in a systematic manner on early pregnancy events, pregnancy and postpartum complications and outcomes, utilization of existing malaria prevention tools, malaria infections and clinical disease, birth outcomes, and follow-up of subsequent offspring.

Eligibility criteria:
inclusion criteria: community census cohort: 1. females of childbearing potential or pregnant females. 2. aged 15 to 49 years. 3. able to provide verbal individual informed consent. health facility cohort: 1. pregnant females 15 to 49 years and their subsequent offspring. 2. resides in or in the health catchment area of kalifabougou and willing to return to the health center for antenatal care (anc) visits. 3. able to provide written individual informed consent for herself and her future offspring(s). exclusion criteria: community census cohort: 1. temporary residence in the study area. 2. other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of an individual participating in the study, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol. health facility cohort: 1. temporary residence in the study area. 2. other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of an individual participating in the study, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.
the effect of scapular exercises in patients with stroke

Conditions: Stroke, Acute

Summary: there is a paucity of research on the correlation between postural control and upper extremity function. analyzing the mechanisms of postural deficits and related problems is believed to give idea for any conceivable advance in future rehabilitation strategies in patients with stroke. the purpose of this study was to examine the effect of scapular exercises on the scapular stability and trunk control. we hypothesized that scapular exercises correct the scapular position and improve postural control. hence the reaching out movement can be applied in a controlled and fluent manner at the end of the treatment.


Eligibility criteria:
inclusion criteria: diagnosed as acute stroke, being able to sit without support, presence of hemiparesis, clinical stability exclusion criteria: shoulder joint dysfunction due to previous musculoskeletal disease, severe dementia, severe visual disturbances that could not be corrected with glasses, severe aphasia, scored ≥ 3 on the modified ashworth scale and refused to participate
phase ii study of pemetrexed in advanced or recurrent gastric cancer after chemotherapy

Conditions: Gastric Cancer

Summary: this phase ii trial aimed to assess the efficacy and safety of pemetrexed in patients with pretreated metastatic gastric cancer.

patients enrolled in this study received pemetrexed 500mg/m2, once every 21 days, until the presence of progressive disease or unacceptable toxicity. all patients took dexamethasone 3.75 mg twice daily, starting from the day before and continuing to the day after the drug administration. patients were instructed to take oral folic acid 400 mg daily beginning 5 days before the first therapy and until the final therapy.patients received vitamin b12 very 3 cycle of chemoherapy. granulocyte colony-stimulating factor (g-csf), granulocyte-macrophage colony-stimulating factor (gm-csf) or erythropoietin (epo) was not allowed, but they could be used when the patients suffered from bone marrow depression.

Eligibility criteria:
inclusion criteria: 1. histological confirmed inoperable or metastatic adenocarcinoma of the stomach or gastro-esophageal junction 2. age between 18 and 80 years 3. ecog performance status of 0 to 2 4. life expectancy ≥ 12 weeks 5. has measurable disease by response evaluation criteria in solid tumors (recist) 6. at least one prior chemotherapy regimen 7. adequate bone marrow function as defined by absolute neutrophil count more than or equal to 2000/mm3 8. platelet count more than or equal to 100,000/mm3 and hemoglobin more than or equal to 8 g/dl 9. adequate renal function defined by creatinine less than or equal to 1.25 × upper limit of normal(uln) and creatinine clearance more than or equal to 60ml/min, 10. adequate liver function defined by bilirubin less than or equal to 1.0×uln aspartate transferase(ast) and alanine transferase(alt) less than or equal to 2.5 ×uln. exclusion criteria: 1. other primary malignancy 2. symptomatic central nervous system metastasis 3. pregnancy or lactation 4. cardiovascular events such as myocardial infarction in the previous 6 months or congestive heart failure 5. ongoing infection 6. inability or unwillingness to interrupt nonsteroidal anti-inflammatory drugs for 2 days before and after pemetrexed administration unwillingness to take folic acid or vitamin b12 supplementation.
neuroimaging markers of alzheimer disease: a longitudinal population study

Conditions: Dementia; Alzheimer Disease

Summary: it is now acknowledged that alzheimer's disease is characterized by a long period of pathophysiological change. developing new strategies to achieve diagnoses as early as possible has become a major goal for therapies aimed at slowing the progression of this disease. while diagnoses currently rely principally on clinical neuropsychology, the typical diagnostic criteria of nincds-adrda are inapplicable in the early stage of the disease. the goal of our project is to identify very early imaging markers for alzheimer's disease among patients with no report of cognitive difficulties. in order to achieve this goal, we propose a longitudinal study in an elderly population cohort.

the amimage2 project that follows amimage1 and mri-3c consists of an imaging study in association with longitudinal epidemiologic cohorts (ami and 3c). the first objective is to investigate the association between the evolution of imaging markers and the evolution of cognitive performance in normal and pathological aging. this objective will be conducted among subjects having already participated in amimage1, thereby permitting the longitudinal study of mri data. an mri exam will also be proposed to 100 subjects (members of the ami and 3c cohorts) in order to provide a third wave of mri (for a longer-term mri follow-up) or a second one for the participants who only had one mri exam in the amimage project. our second objective is cross-sectional and will study the imaging parameters of subjects presenting signs of cognitive decline over the previous 4 years (through the follow-up conducted in the ami cohort). finally, an additional objective will consist in a comparison between two populations very contrasted in terms of cognitive reserve: ami (very low education level in rural area) and 3c (higher level of education in urban area).

Eligibility criteria:
inclusion criteria: * at least 65 years old * be retired from agricultural profession * live in rural area in gironde (france) exclusion criteria: * lefthanded * having a dementia (mmse \< 13) * having a vascular cerebral accident * parkinson disease * rmi exclusion criteria * \[18f\]-fdg pet scan exclusion criteria * poor health condition does not allowing transport to neuroimaging service

Keywords: dementia alzheimer's disease diagnostic biomarkers neuroimaging pet mri mild cognitive impairment
study of bb21217 in multiple myeloma

Conditions: Multiple Myeloma

Summary: study crb-402 is a 2-part, non-randomized, open label, multi-site phase 1 study of bb21217 in adults with relapsed/refractory multiple myeloma (mm).

part a of the study will be dose escalation followed by part b, an expansion cohort. following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (bb21217). following manufacture of the drug product, subjects will receive lymphodepletion prior to bb21217 infusion. all subjects will then be followed for up to 60 months in study crb-402. all subjects who complete the study, as well as those who withdraw from the study after receiving bb21217 for reasons other than death or meeting the early termination criteria, will be asked to continue to undergo long-term follow-up in a companion study.

Eligibility criteria:
inclusion criteria: * ≥18 years of age at the time of signing informed consent * eastern cooperative oncology group (ecog) performance status 0 or 1 * diagnosis of mm with relapsed or refractory disease and have had at least 3 different prior lines of therapy with previous exposure to pi, imids, and a cd38 antibody. have undergone at least 2 consecutive cycles of treatment for each therapy, unless pd was the best response to the therapy. refractory to their last line of therapy. * subjects must have measurable disease exclusion criteria: * subjects with known central nervous system disease * inadequate hepatic function * inadequate renal function * inadequate bone marrow function * presence of active infection within 72 hours * subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control * significant co-morbid condition or disease which in the judgment of the investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions * known human immunodeficiency virus (hiv) positivity * known hepatitis a virus (hav), hepatitis b virus (hbv) or hepatitis c virus (hcv) positivity with evidence of ongoing infection. * pregnant or lactating women * previous history of an allogeneic bone marrow transplantation, treatment with any gene therapy based therapeutic for cancer, or bcma-targeted therapy * inadequate pulmonary function defined as oxygen saturation (sao2) \<92% on room air * subjects who have a history of plasma cell leukemia, active plasma cell leukemia, waldenstrom's macroglobulinemia, poems, or clinically significant amyloidosis
chronic low back pain rehabilitation in primary care: a pilot study

Conditions: Chronic Low Back Pain

Summary: up to now, only little research has been performed in tailoring treatment of patients with chronic low back pain (clbp). it would be interesting to evaluate a biopsychosocial intervention in patients with a moderate to high level of disability and in whom the contributing role of psychosocial factors to this disability is mild to moderate (wpn3-). nowadays, these patients receive cognitive behavioral-based treatments in multidisciplinary rehabilitation settings but might also benefit from treatments based on these multidisciplinary rehabilitation treatment principles when provided by specifically trained primary care physical therapists. therefore, the aims of this pilot-study are to evaluate the feasibility of a specifically for primary care physiotherapist developed biopsychosocial intervention ("back on track" intervention) in wpn3- classified patients, and to evaluate whether this "back on track" intervention results in a significant improvement in functional disability in this subgroup of patients.


Eligibility criteria:
inclusion criteria: * chronic low back pain; defined as pain between scapulae and gluteal region, whether or not with radiation towards one or both legs, present for at least three months. * presence of contributing social and psychological factors, however not complex (wpn3-classification). * age between 18 and 65 year * sufficient knowledge of the dutch language * acceptance towards the biopsychosocial approach instead of biomedical approach exclusion criteria: * chronic low back pain attributable to e.g. infection, tumour, osteoporosis, fracture, structural deformation, inflammatory process, radicular syndrome or cauda equina syndrome * pregnancy * any suspicion of an (underlying) psychiatric disease, for which psychiatric treatment is better suited, according to the expert opinion of the consultant in rehabilitation medicine.

Keywords: low back pain chronic pain cognitive behavioral therapy primary health care physical therapy
assessment of n-95 facemask for use in covid-19 pandemic in case of shortage of personal protective equipment

Conditions: Coronavirus Infection; Disease Prevention

Summary: the purpose of this study is to assess the safety and efficiency of an assembled modified mask in protecting health care workers against coronavirus in case of any personal protective equipment shortage. at least 20 healthy participants will be recruited to try the modified mask. the modified masks will be made from masks that are already available as well as filters available in the pulmonary department at the oklahoma city va health care system


Eligibility criteria:
inclusion criteria: 1. all individuals older than 18 years of age, and willing to participate in the study exclusion criteria: 1. individuals with known severe copd/emphysema, obesity hypoventilation or hypercapnic condition 2. individuals with allergy or reactions to latex or masks 3. individuals reporting dyspnea or unable to breathe comfortably in these masks 4. claustrophobic individuals 5. inability to create a proper seal while inhaling through a closed filter (see below) 6. individuals who cannot safely apply and remove these masks

Keywords: 2019 novel coronavirus disease 2019 novel coronavirus infection covid-19 pandemic covid-19 virus disease covid19 covid-19 virus infection n-95 respiratory protective devices protection from respiratory infecton safety efficacy pandemic
lung inflammation and lung metastases from breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to find out if there is a link between cigarette smoking, inflammation and the spread of breast cancer to the lung. we think that women who are current or former smokers may be at increased risk for breast cancer spreading to the lung compared to women who have never smoked. smoking causes inflammation in the lung in some women. researchers at memorial sloan-kettering (mskcc) think that smoking-related lung inflammation may increase the chance of breast cancer spreading to the lung. in order to find out whether inflammation plays a role in breast cancer spreading to the lung, we will measure a urinary marker of lung inflammation. this will allow us to determine if this marker is more commonly elevated in women with breast cancer that has spread to the lung compared to those without breast cancer in the lung. we will also collect dna from blood to have the opportunity to determine if there are differences in dna in women with or without breast cancer that has spread to the other sites including the lung. we will also collect blood to determine if we can identify risk factors for the spread of breast cancer to the lungs.


Eligibility criteria:
inclusion criteria: * registered patient at mskcc * histologically proven breast cancer. it is not necessary that pathology be reviewed at mskcc * age ≥18 years group 1 (a and b) * diagnosed with metastatic breast cancer on biopsy or imaging study. * patients will be considered to have lung metastases, and will be assigned to group 1a if any of the following criteria are met, otherwise patients will be assigned to group 1b "no known lung metastases," biopsy-proven lung metastasis. * pleural effusion with cytologic evidence of malignancy. * pleural effusion, exudative in character, without alternative explanation and attributed, in the opinion of the clinician to metastatic disease. * symptoms attributable to lung metastases and a radiological pattern interpreted by a radiologist as suspicious for metastatic disease. * any pulmonary nodule on chest radiograph, ct scan, pet-ct or mri, which is interpreted by the clinician and radiologist to be metastatic in etiology, whether or not a biopsy was performed, and regardless of symptoms. * a radiographic pattern interpreted by a radiologist as consistent with lymphangitic carcinomatosis. group 2 (controls) * history of early breast cancer and currently no evidence of disease exclusion criteria: * inability to provide written informed consent. * inability to complete smoking and nsaid questionnaire. * steroid use within the previous 4 weeks. * radiotherapy to the breast, chest wall or axilla within the previous 3 months. * men with breast cancer.

Keywords: lung inflammation lung metastases 10-115